Ever since the appearance of the new revision of the ISO 9001 standard was published, I see incessant discussions of frightened Quality Assurance people on the differences between the revisions of 2015 and that of 2008. There are also a multitude of classes and training promising to help with the transition from the previous to the new.
In Quality Assurance, how does any process begin? From a definition, born of necessity, with the guidance, for instance, of the ISO 9001 standard, which instructs us to identify the processes in our organization and define them. That is, to decide how we perform them, which we may put in writing, so everyone can verify in the future, if they forget. We call that “procedure”.
In all my long years of experience, I found that most people think Quality Assurance deals with products, specifications and their parameters, or requirements. Various management members often hold the conviction that it is Quality Assurance department which is responsible for the quality of their products, whereas they do not fulfill these specifications. But is that really so?